FDA Will Not Require IND for Fecal Microbiota Transplant

The FDA has announced that it will not require an investigational new drug application for fecal microbiota as a treatment for C. difficile infections that do not respond to standard treatments, according to report by the American Gastroenterological Association.

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Carrie Pallardy

No IND is required as long as physicians obtain informed consent from the patient.

Though the FDA does not require an IND, the agency urges physicians planning to use FMT to submit an IND first.

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